The FDA has once again turned away Minerva’s schizophrenia drug roluperidone, requesting “at least one” additional well-controlled study.
While roluperidone met the primary endpoint in a Phase IIb study for negative symptoms in patients with schizophrenia, regulators said in a complete response letter that the trial was “insufficient on its own” to establish efficacy. A Phase III readout in 2020 failed to meet statistical significance. Regulators also want to see a safety review including more patients at the proposed 64 mg dose, as well as data on concomitant use with other antipsychotics, Minerva announced on Tuesday.
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